Select Agents/Toxins

What do I do if I have a select agent in my laboratory or have questions about select agents?

OHSU must register with and be certified by the CDC and/or USDA if any individuals working in an OHSU facility possess, use or transfer select agents. If you currently possess (or are considering the use of) a select agent please contact one of the Responsible Officials (ROs):

OHSU Main Campus Biosafety Officer, (503) 494-0655, or
OHSU West Campus Biosafety Officer, (503) 748-1226 or 
send an e-mail to ibc@ohsu.edu.

What is a select agent or toxin ("select agent")?

A listing of HHS select agents and toxins in the new select agent regulation (42 CFR 73) is available at http://www.cdc.gov/od/sap/docs/salist.pdf.

What is a High Consequence Pathogen and Toxin?

High Consequence Livestock Pathogens and Toxins are agents that the USDA considers to have the potential to pose a severe threat to animal or plant health, or to animal or plant products. A list of the agents may be found at: http://www.aphis.usda.gov/vs/ncie/bta.html.

Agents that appear on both the HHS and USDA list of agents and toxins are referred to as "Overlap Agents." The list of overlap agents is available at: http://www.cdc.gov/od/sap or http://www.aphis.usda.gov/vs/ncie.

The plant pathogens listed by USDA have been deemed a threat to plant health or products. The list of plant agents and toxins is available at http://www.aphis.usda.gov/ppq/permits.

What is excluded from the new select agent regulation (42 CFR 73)?

The following are excluded from the regulation:

• Select agents or toxins that are in their naturally occurring environment, provided that it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
• Non-viable select agent organisms or nonfunctional toxins.
• The vaccine strain of Junin virus (Candid #1).
• It is possible under the new rule to apply for exclusion for any attenuated agent or toxin using an appropriate form obtainable from CDC. Exclusions for specific strains may be granted if the attenuated strain is determined not to pose a significant public health or safety threat. Exclusions will be published in the notice section of the Federal Register and will be listed on the CDC website at http://www.cdc.gov/od/sap.

Exclusions for entities with specific quantities of toxins under the control of a principal investigator at a given time are also detailed in the regulation (see number 5, below).

What are the changes regarding the list of agents with the new regulation?

• Two agents (viruses causing Hantavirus pulmonary syndrome and yellow fever virus) have been removed from the list. One toxin (aflatoxin) was removed from the list previously published in 42 CFR 72.6.
• Several agents have been added to the list of HHS agents, including Cercopithecine herpes virus 1
• (Herpes B virus), Monkeypox virus, Coccidioides posadasii, and Shiga-like ribosome inactivating proteins.
• Nomenclature changes are as follows:
Equine Morbillivirus Virus has been renamed to Nipah and Hendra Complex viruses; Clostridium botulinum was updated to include botulinum neurotoxin producing species of Clostridium. Tick borne encephalitis complex (flavi) viruses are now specified by individual name (Central European Tick-Borne encephalitis (CTBE); Far Eastern Tick-borne encephalitis (including Russian Spring and Summer encephalitis (RSSE), Kyasanur Forest disease, and Omsk hemorrhagic fever). The listing of Variola minor virus (Alastrim) is added to Variola major (smallpox) virus.

Toxins are regulated based on potency and quantity (as opposed to potency only or LD50 values as in 42 CFR 72.6). Entities that do not at any time have more than the following aggregate amounts (in the purified form or in combinations of pure and impure forms) under the control of a principal investigator are excluded from requirements of the regulation:

Based upon consultations with subject matter experts and a review of relevant published studies and information provided by the entities requesting the exclusions, HHS and USDA have determined that the following attenuated strains are not subject to the requirements of 42 CFR Part 73 and 9 CFR Part 121 if used in basic or applied research, as positive controls, for diagnostic assay development, or for the development of vaccines and therapeutics.

However, an individual or entity that possesses, uses, or transfers an excluded attenuated strain will be subject to the regulations if there is any reintroduction of factor(s) associated with virulence or other manipulations that modify the attenuation such that virulence is restored or enhanced.

Attenuated strains of HHS select agents and toxins excluded:

• Yersinia pestis strains (e.g., Tjiwidej S and CDC A1122) devoid of the 75 kb low-calcium response (Lcr) virulence plasmid. (effective 2-27-2003
Background 

Attenuated strains of Overlap select agents and toxins excluded:

• Bacillus anthracis strains devoid of both plasmids pX01 and pX02. (effective 2-27-2003)
Background
• Bacillus anthracis strains devoid of the plasmid pX02 (e.g., Bacillus anthracis Sterne, pX01+pX02-). (effective 2-27-2003)
Background
• Francisella tularensis subspecies novicida (also referred to as Francisella novicida) strain, Utah 112 (ATCC 15482). (effective 2-27-2003)
Background
• Francisella tularensis subspecies holartica LVS (live vaccine strain; includes NDBR 101 lots, TSI-GSD lots, and ATCC 29684). (effective 2-27-2003)
Background

For additional reference, including links to the select agent regulation text and additional FAQs, please see: http://www.cdc.gov/od/sap/index.htm